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Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells

RecruitingPhase 1

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Patients 18 years of age or older who are scheduled to undergo anterior cruciate ligament (ACL) reconstruction with bone-to-bone (BTB) patellar tendon autograft with the Principal Investigator (PI).
* Receiving post-surgery physical therapy at a Houston Methodist physical therapy (PT) clinic.

Exclusion Criteria:

* Under 18 years of age
* Prior surgery on affected knee
* Diabetes
* Root repair, inflammatory arthropathy, or any other concomitant procedure that cannot follow an accelerated PT protocol or any concomitant procedure that the PI deems exclusionary
* Unable to attend physical therapy at Houston Methodist
* Vulnerable populations
* Immunocompromised patients such as those being treated for cancer, kidney failure, etc.
* Heart disease (including systolic blood pressure \>180 mm Hg or heart failure)
* Active infections
* Non-English-speaking patients
* Any known metal implants or allergy to contrast agents
* Pregnancy (as part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative result is required to proceed with surgery per SOC and thus, participate in the study) and those planning to become pregnant during the duration of the study
* Any condition with known bleeding disorders, thrombus formation risk factors, or overlying wound and skin infections
* Any condition in the opinion of the primary investigator that would compromise the integrity of the data collection or outcomes being assessed
* Any other medical condition that in the opinion of the primary investigator would constitute a relative contraindication to study participation (e.g., Ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, SLE, scleroderma, polymyositis, Ehlers-Danlos syndrome, osteoporosis)

About the study

This study is designed as a prospective, open label, single arm pilot clinical study that will establish the safety and efficacy of a single injection of mesenchymal stromal cells in patients. Each subject will receive one intra-articular injection of autologous mesenchymal stromal cells derived from infrapatellar fat pad (FP-MSC) tissue samples collected from the subject during anterior cruciate ligament (ACL) reconstruction surgery.

What is being tested

Sponsor: The Methodist Hospital Research Institute · Participants: 15 · Started: Mar 24, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT06798623

Locations in the U.S.

TexasHouston Methodist Hospital, Houston

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.